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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037163
Receipt No. R000042344
Scientific Title The effect of mastication on postprandial glucose metabolism
Date of disclosure of the study information 2019/06/25
Last modified on 2019/12/25

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Basic information
Public title The effect of mastication on postprandial glucose metabolism
Acronym The effect of mastication on postprandial glucose metabolism
Scientific Title The effect of mastication on postprandial glucose metabolism
Scientific Title:Acronym The effect of mastication on postprandial glucose metabolism
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to clarify the effect of physiological mastication (chewing) on postprandial glucose metabolism and gastric excretion.
Basic objectives2 Others
Basic objectives -Others A participant will conduct 2 trials, mealtests with and without mastication. In the mealtest without mastication, participant will take a grinded testmeal, which has same nutrient composition as the trial with mastication, dissolved in water. The effect of mastication itself on postprandial glucose metabolism and gastric excretion independent of nutrient composition of the testmeal.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes plasma glucose levels (baseline, 15, 30, 45, 60, 90, and 120 min after taking a testmeal)
Key secondary outcomes serum insulin and acetoaminophen levels, plasma GLP-1 level, postprandial energy expenditure

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 a bout of mealtest with mastication
Interventions/Control_2 a bout of mealtest without mastication
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy adults with no present illness
Key exclusion criteria a person taking oral hypoglycemic agents or insulin injection/a person with peptic ulcer/a person suffering from or has a history of aspirin-indiced asthma/oral diseases (doesnot matter whether having any prosthetic appliances or not)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hisayo
Middle name
Last name Yokoyama
Organization Osaka City University Graduate School of Medicine
Division name Environmental Physiology for Exercise
Zip code 558-8585
Address 3-3-138, Sugimoto, Sumiyoshi-ku, Osaka City
TEL 06-6605-2947
Email yokoyama@sports.osaka-cu.ac.jp

Public contact
Name of contact person
1st name Hisayo
Middle name
Last name Yokoyama
Organization Osaka City University Graduate School of Medicine
Division name Environmental Physiology for Exercise
Zip code 558-8585
Address 3-3-138, Sugimoto, Sumiyoshi-ku, Osaka City
TEL 06-6605-2947
Homepage URL
Email yokoyama@sports.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization JAPAN VASCULAR DISEASE RESEARCH FOUNDATION
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka City University 0Certified Review Board for Medical Research
Address 1-2-7-601, Asahi-Machi, Abeno-ku, Osaka City
Tel 06-6645-3456
Email ethics@med.osaka-cu.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪市立大学環境生理実験室

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2019 Year 04 Month 25 Day
Date of IRB
2019 Year 04 Month 25 Day
Anticipated trial start date
2019 Year 07 Month 22 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 25 Day
Last modified on
2019 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042344

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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